Relovair combines vilanterol, a novel long-acting beta agonist (LABA),
and fluticasone furorate, an inhaled corticosteroid (ICS). Both
components are analogs respectively of salmeterol and fluticasone
propionate, the components of Advair. But unlike Advair, Relovair is
suitable for once-daily dosing. The sponsors have completed extensive
phase II trials with each component, but the future of those monotherapy
programs is uncertain. They have also completed one phase II trial in
COPD with the combination (Relovair) and have moved the program into
phase III in asthma and COPD. The asthma trials target ex-US filings,
whereas the COPD trials will support Relovair's initial entry into the
US market.

Specific to vilanterol (monotherapy) and more broadly to Relovair, LABA
safety has been the focus of ongoing regulatory concern and FDA's
positions are still evolving. This report explores that history in
detail, looking at the nuanced implications for Relovair and the
associated programs. It also reviews the likelihood of success in phase
III, the competitive landscape and prospects for Relovair's market
success.